Uli Hack­sell, Cere­cor

Just a few days af­ter Cere­cor was pum­meled $CERC by the news that its lead de­pres­sion drug, CERC-301, failed a mid-stage study, the mi­cro­cap com­pa­ny has been forced to ad­mit that its top drug over­all flopped in a Phase II for nico­tine with­draw­al.

CERC-501, re­cent­ly the sub­ject of some con­sid­er­able mar­ket buzz af­ter a sim­i­lar treat­ment from Alk­er­mes scored pos­i­tive da­ta in two late-stage tri­als, failed the tri­al of 71 heavy smok­ers. But the biotech now plans to sol­dier on in ma­jor de­pres­sion, look­ing to see if it can make progress in a field lit­tered with the corpses of dead drug pro­grams.

Cere­cor’s al­ready bat­tered shares plunged 43%, drop­ping in­to pen­ny stock ter­ri­to­ry in pre-mar­ket trad­ing.

“There is pre­clin­i­cal and re­cent clin­i­cal ev­i­dence that strong­ly sup­port the po­ten­tial use of oth­er KOR an­tag­o­nists as nov­el med­i­cines for the treat­ment of mood- and stress-re­lat­ed con­di­tions, such as MDD and anx­i­ety dis­or­ders. We be­lieve that our KOR an­tag­o­nist, CERC-501, has sim­i­lar po­ten­tial,” added Dr. Uli Hack­sell, Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer at Cere­cor. “We will now turn our fo­cus to prepar­ing CERC-501 for a Phase 2/3 clin­i­cal tri­al as an ad­junc­tive treat­ment of MDD in pa­tients with an in­ad­e­quate re­sponse to stan­dard an­ti­de­pres­sant ther­a­pies. We hope to ini­ti­ate this tri­al in the sec­ond half of 2017.”

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.